Description

Acaluxen capsule: Each capsule contains Acalabrutinib INN 100 mg.

 

Product Features

Product Name	:	Acaluxen
Generic Name	:	Acalabrutinib
Formulation	:	Capsule
Available Pack Size	:	60’s Pot
Available Strength	:	100 mg
Registrations	:	Export Only

 

Acalabrutinib is used to treat certain types of cancer, specifically blood cancers such as mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).

 

How does Acalabrutinib work (Acaluxen)

Acalabrutinib is a type of medication that blocks a protein called Bruton’s tyrosine kinase (BTK), which is involved in the growth and spread of certain cancers, especially those affecting B cells.

 

When you take acalabrutinib, it forms a strong connection with a specific part of the BTK protein, essentially shutting it down. This stops BTK from doing its job, which is to activate pathways that help B cells grow and move around the body.

 

In simpler terms, BTK is like a switch that turns on activities in B cells, such as making them multiply, move, and stick to other cells. Acalabrutinib flips this switch off.

 

Studies show that acalabrutinib can stop BTK from sending signals that make cancerous B cells grow and survive. By blocking these signals, it helps slow down or even stop the cancer from getting worse.

 

In summary, acalabrutinib is a medication that blocks a protein called BTK, which cancer cells need to grow and spread. By blocking BTK, it helps stop the cancer from progressing.

 

Dose & Administration

Recommended Dosage: Acaluxen is typically taken orally at a dose of 100 mg every twelve hours until either the disease stops responding to the treatment or if the side effects become too severe.

How to take Acalabrutinib 100 mg capsule: Patients should swallow the capsules whole with water and avoid opening, breaking, or chewing them. Acaluxen can be taken with or without food.

Missed Dosage: If a dose is missed by more than 3 hours, it should be skipped, and the next dose should be taken at the usual time. Extra capsules should not be taken to make up for a missed dose.

 

Dose Modification

If adverse reactions occur, the dosage of Acaluxen may be reduced to as low as 100 mg daily until the side effects improve to a mild level (Grade 1) or return to the level before starting the treatment. If the adverse reactions happen more than four times, Acaluxen may be discontinued.

 

Acalabrutinib side effects

Hemorrhage: Serious bleeding events, including fatal ones, have occurred in some patients. Approximately 2% of patients experienced Grade 3 or higher bleeding events, including gastrointestinal and intracranial bleeding. About half of the patients experienced bleeding of any grade. Patients should be monitored for signs of bleeding, especially if they are also receiving antiplatelet or anticoagulant therapies.

 

Infection: Serious bacterial, viral, or fungal infections, including fatal ones, have been reported. About 18% of patients experienced Grade 3 or higher infections, with pneumonia being the most common. Hepatitis B virus reactivation and progressive multifocal leukoencephalopathy have also occurred. Patients should be monitored for signs and symptoms of infection and treated appropriately.

 

Cytopenias: Grade 3 or 4 cytopenias, including neutropenia, anemia, and thrombocytopenia, have been observed. Regular monitoring of complete blood counts is recommended during treatment.

 

Second Primary Malignancies: About 11% of patients developed second primary malignancies, with skin cancer being the most common. Patients should be advised to protect themselves from sun exposure.

 

Atrial Fibrillation and Flutter: A small percentage of patients experienced atrial fibrillation or flutter. Monitoring and appropriate management are recommended.

 

Acalabrutinib Drug Interactions

Strong CYP3A Inhibitors: Co-administration with strong CYP3A inhibitors can increase Acalabrutinib levels, potentially leading to toxicity.

Moderate CYP3A Inhibitors: Co-administration with moderate CYP3A inhibitors may also increase Acalabrutinib levels, increasing the risk of toxicity.

Strong CYP3A Inducers: Co-administration with strong CYP3A inducers can decrease Acalabrutinib levels, reducing its effectiveness.

Gastric Acid Reducing Agents: Taking Acalabrutinib with proton pump inhibitors, H2-receptor antagonists, or antacids may decrease Acalabrutinib levels. If needed, consider using alternatives like H2-receptor antagonists or antacids to minimize this interaction.

 

Use in Specific Population

Pregnancy

During pregnancy, Acalabrutinib poses potential risks to unborn babies, as indicated by animal studies. However, its impact on pregnant women remains unknown due to lack of data. Animal research suggests that Acalabrutinib administration during pregnancy can lead to reduced fetal growth. It’s crucial to advise pregnant women about these potential risks, though the background risk of birth defects and miscarriage in this context remains uncertain.

 

Lactation

Regarding lactation, there’s limited information available about the presence of Acalabrutinib or its metabolites in human milk. However, studies in rats have shown the presence of Acalabrutinib and its active metabolite in their milk. Therefore, breastfeeding while taking Acalabrutinib is not recommended, and lactating women should wait at least two weeks after their final dose before breastfeeding to avoid potential adverse reactions in their infants.

 

Pediatric Use

As for pediatric use, the safety and efficacy of Acalabrutinib have not been established in children, highlighting the need for further research in this population.

 

Geriatric Use

In terms of geriatric use, clinical trials involving Acalabrutinib included a substantial number of older patients, with no significant differences in safety or efficacy observed between those aged 65 and older and younger patients.